More batches of EpiPen® are withdrawn

06 April 2017

MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

The product is an auto-injector (syringe) containing adrenaline designed for self-administration in acute serious hypersensitivity reactions (acute, severe anaphylaxis). On 16 March 2017, MEDA withdrew the adrenaline product EpiPen® 300 micrograms/dose with batch number: 5FA665B.

As a precautionary measure, MEDA has decided to withdraw four more batches of the adrenaline pens, because the company cannot rule out that there is a risk that the auto-injector does not work in these batches.

MEDA still estimates that there is a very low risk that EpiPen®/EpiPen® Jr does not work, since the withdrawal is based on only two reports of a defective EpiPen® worldwide. This means that there is a low risk that patients who experience a severe hypersensitivity reaction cannot treat themselves with an adrenaline injection.

Patients can check the batch number on the EpiPen®/EpiPen® Jr.

The numbers of the currently withdrawn batches

Lot/Batch

Product

Product number

Expiry date

5ED824AB

EpiPen Jr

437938

04/2017

6ED117C

EpiPen Jr

437938

08/2017

6FA292D

EpiPen

578818

09/2017

6FA293X

EpiPen

578818

09/2017

The number of the batch withdrawn on 16 March 2017

Lot/Batch

Product

Product number

Expiry date

5FA665B

EpiPen

578818

03/2017

There are other product numbers and batches of EpiPen®/EpiPen® Jr on the market that are not affected by this withdrawal. Please note that EpiPen® parallel imported by Orifarm and 2care4 are not affected by the withdrawal.

Patients are recommended to check the batch number, or ask relatives or the pharmacy for help. If the product has one of the four batch numbers mentioned, you should go to your pharmacy as soon as possible and have it replaced by a new EpiPen®/EpiPen® Jr. If possible, you should go to the pharmacy where you bought the pen.

It is important that you keep your pen until you have had it replaced with a new one.

If you experience a severe hypersensitivity reaction before you have had the pen replaced, you should use the EpiPen®/EpiPen® Jr – as instructed by your doctor. However, note that there is a low risk that the pen does not work. If you need to use the pen and it does not work, please call 112.  

You are encouraged to avoid activities associated with an increased risk of severe hypersensitivity reactions.

If your product does not carry one of the batch numbers mentioned above, you do not need to take any further action.

Pharmacies are encouraged to help patients check the batch number. Products from the defective batches will be replaced, at no cost to patients, by a new EpiPen®/EpiPen® Jr until the expiry date of the product.

Doctors should pay attention to the withdrawal.

About EpiPen® and EpiPen® Jr

EpiPen®/EpiPen® Jr is an auto-injector (syringe) containing adrenaline, which stimulates the heart and causes blood vessels to contract. The product is a first-line treatment for a sudden life-threatening allergic reaction (anaphylaxis). For example, an anaphylactic reaction triggered by insect stings or by food.

An anaphylactic shock involves hypotension and breathing difficulties. EpiPen®/EpiPen® Jr is intended for injection of adrenaline into a muscle, and patients can administer the injection themselves, for example to manage their sensitivity to insect stings.

Link to MEDA’s press release (in Danish)

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